NCT04416581

Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy

A Multi-centre, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Phase 4 Efficacy and Safety Study of P-CAB (Tegoprazan 50 mg Once Daily) Compared With PPI (Rabeprazole 20 mg Once Daily) to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,320 (estimated)
• Sponsor: Duk-Woo Park, MD · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB (tegoprazan 50 mg once daily) as compared with standard PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with known cardiac and vascular disease receiving chronic use of antithrombotic drugs (either antiplatelets, OAC, and its combinations) who are at high GI bleeding risk. The primary hypothesis is that P-CAB (experimental arm) would non-inferior to PPI (standard arm) with respect to the rate of the primary composite end point of GI events at 12 months after randomization.

Detailed description

Before randomization phase, one lead-in subject (N = 300 patients) will be enrolled to perform safety surveillance of standard-dose tegoprazan (50 mg for 6 months) and to ensure the safety of tegoprazan (safety surveillance phase). Data on lead-in subjects will not be included in the data set used for primary analyses. The safety of tegoprazan will be estimated SIAEs(Special Interest Adverse Events) as follows; Composite Event 1. liver function abnormalities 2. hypergastrinemia, or 3. enteric infection Definitions * liver function abnormality: defined as AST or ALT\>3× upper limit of normal or two consecutive measurements of total bilirubin \>2 x upper limit of normal * hypergastrinemia * enteric infection including C.difficile infection If there are any new tegoprazan-related findings, it will be considered in the estimation. If there is no safety concern during safety surveillance phase, investigator-driven, randomized, double-blind, double-dummy, active-controlled, clinical trial (N =3,100 patients) will be subsequently performed (randomization phase).

Conditions

• Coronary Artery Disease
• Percutaneous Coronary Intervention
• Acute Coronary Syndrome
• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	PPI	rabeprazole 20mg + tegoprazan 50 mg placebo, once daily.
DRUG	P-CAB 50	tegoprazan 50 mg + rabeprazole 20mg placebo, once daily.

Timeline

• Start date: 2021-05-12
• Primary completion: 2026-09-30
• Completion: 2027-12-31
• First posted: 2020-06-04
• Last updated: 2025-12-30

Locations

43 sites across 1 country: South Korea